Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guide wire may be advanced through the needle and into the patients blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator.
A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
Upon completing the procedure, the devices and introducer sheath would be removed, leaving a puncture site in the vessel wall. Traditionally, external pressure would be applied to the puncture site until clotting and wound sealing occur, however, the patient must remain bedridden for a substantial period of time after clotting to ensure closure of the wound. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physicians or nurses time. It is also uncomfortable for the patient, and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
Various apparatus have been suggested for percutaneously sealing a vascular puncture by occluding the puncture site. For example, U.S. Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the use of a biodegradable plug that may be delivered through an introducer sheath into a puncture site. Another technique has been suggested that involves percutaneously suturing the puncture site, such as that disclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.
Increasingly, more sophisticated apparatus are being developed to position a vascular closure device and percutaneously sealing the vascular puncture. For instance, “bleed back” indicators have been suggested for use as positioning devices that are percutaneously inserted into a blood vessel. For example, U.S. Pat. No. 5,676,974, issued to Kensey et al., discloses a bleed back lumen intended to facilitate positioning of a biodegradable plug within a puncture site. This device, however, requires that an anchor of the plug be positioned within the vessel, and therefore, may increase the risk of over-advancement of the plug itself into the vessel.
Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al., discloses a deployable loop that may be advanced through a sheath into a vessel. The loop is intended to resiliently expand to engage the inner wall of the vessel, thereby facilitating holding the sheath in a desired location with respect to the vessel.
In still another example, U.S. Patent Publication No. 20040153123,applied for by Palermo et al., describes an apparatus that includes a plurality of expansion members that selectively engage the inner wall of the vessel. A triggering system is then used to release and deploy an expandable closure element which engages the vessel wall and closes the access site. This device is configured for a single-use and locks a sheath and the triggering system in place such that it cannot be re-used. Additionally, because the device becomes locked during use, it cannot later be reused or used to demonstrate how to use the device.
Accordingly, apparatus and methods for delivering a device for closing a vascular puncture site or other opening through tissue would be useful. Additionally, it would be beneficial to have a delivery device that can be easily reset so as to be re-used or used for demonstration purposes. Additionally, apparatus for resetting a delivery device without requiring the delivery device to be broken apart after each use or demonstration would also be beneficial.